ISO 9001:2000 7.3.5 "Verification" and 7.3.6 "Validation"- Clarification

J

JkelleyCDS

#1
My third and final post of the day stemming from my pre-assessment this week was regarding Design and Development.

The auditor indicated that I had to have proof of verification and validation. The way I explained it to him is:

1. Our verification process is by performing a first article test on prototypes proving that the outputs do meet the inputs of the design.

2. Our validation is doing production functional testing to validate that all deliverables meet customer specifications/ inputs.

He mentioned that I was lacking on the validation part. He said the validation should be how the customer uses the product and that we should gather customer feedback indicating the part conforms to their expectations.

I don't get it? The customer inputs are verified (i.e. customer requirements) which is what the customer wants (by prototype testing). The validation is that the inputs are met by functional test for all deliverable goods (part meets customer required specs).

Why is the feedback needed for validation? I understand that customer satisfaction and customer feedback is a requirement and my company is performing that. How does that fall under Design and Development validation?

Again, I am confused... what am I not understanding?

Thanks again folks!
 
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BradM

Staff member
Admin
#2
Re: ISO 9001:2000 7.3.5 "Verification" and 7.3.6 "Validation"- Clarification???

Hello! We're glad you dropped by!:bigwave:

If you haven't looked, there is an existing thread where this very subject has been discussed. If you are so inclined, you might want to start there and read it. I would pay particular attention to the definitions provided by Randy in that thread.

verification vs. validation

See if that helps.:)
 
B

Bob Bonville

#3
Re: ISO 9001:2000 7.3.5 "Verification" and 7.3.6 "Validation"- Clarification???

I may be wrong on this, in fact I would love to hear more on the subject. I think your FAI can benefit from some of your V&V activities. Not having gone through either one, but having studied the requirements of both I think, in part, some of the FAI requirements could be met if you can produce your V&V records.

Thoughts?
 
J

JkelleyCDS

#4
Re: ISO 9001:2000 7.3.5 "Verification" and 7.3.6 "Validation"- Clarification???

Thank you all for your feedback.

I think I have a better idea on how to address this. The product is our off the shelf design where custom changes can be made suitable to the customer's inputs.

When it comes to validation, in this case, I would be gathering customer feedback that the product does indeed work to their expectations.

For some background, my company takes the inputs from a potential customer and actually performs the Engineering work for them, meaning sometimes the customer can't put or doesn't understand the design themselves.

To close the loop I am thinking that the inputs is the spec sheet or parameters a customer wants, the verification is our internal R&D results (i.e. FAI), and the validation is gathering customer feedback on how it is working for them.

The validation is not a measurable item, meaning either it works or doesn't in the customer's eyes, but it can be measured via survey or feedback.
 

Kevin Mader

One of THE Original Covers!
Staff member
Admin
#5
Re: ISO 9001:2000 7.3.5 "Verification" and 7.3.6 "Validation"- Clarification???

JkelleyCDS,

Using post market surveillance data might constitute a retrospective validation. This is not generally the preferred approach, but it can be effective in many industries. Aerospace, Medical Device and Pharma companies might end up in large lawsuits if they did, but widget makers might be alright in using this approach.

Your auditor might be concerned that your approach might be too late and less effective (and efficient). Waiting to hear that your customer would like you to change your widget to red rather than blue might mean you have a warehouse of slow moving/no moving products. Also, validation is from the customer's perspective. My feeling here is that you might confirm that you are meeting an intended use or requirement of the customer, but you don't really know unless you are the customer (and only a small part of the greater population).

Read the link that Brad provided. Lot's of discussion there regarding what the differences are. But to a degree, your argument should have been fairly successful. The auditor might have been looking for prospective data.

Regards,

Kevin
 
W

w_grunfeld

#6
Re: ISO 9001:2000 7.3.5 "Verification" and 7.3.6 "Validation"- Clarification???

I thought this debate was over ....just looked in and found it is still kicking.
My thoughts are that you are both wrong.
Both verification and validation are activities to ensure that the design outputs meet design inputs. The main diferrence is that verification focuses on the primary or key features and is performed earlier in the development cycle, thus could use models, engineering analysis, prototypes and so on while validation completes the verification by carrying out tests on first article(s) representing not only the design but also the manufacturing process and checking that the spec limits are met (or changing the specs limits accordingly). Say for a car that is designed among many other things to have a top speed of 138 miles/hr, this is a design input that is verified to some extent in the framework of verification but cannot completely be validated until a few actual production items are ready and road tested under controlled conditions (highway, city driving, etc)
The involving of customers requirements in validation in my opinion is a misunderstanding. Whenever there are clear customer requirements or even just expectations , these are likely already in the design inputs. Nobody in his right mind is going to design a product that does not take into account customer's requirements when these are known. Of course there are cases of products where the manufacturer can only guess (rightly or wrongly) what the market would like. But the organization should still validate the perceived requirements before placing the product on the market. Otherwise , after the fact how can the organization know in case of negative market feedback wether these are due to having guessed wrongly what the market wants or perhaps the guess was correct but the product was never fully validated to ascertain that it really performs as intended?
Customer satisfaction is on another plane and has nothing to do with the design and development cycle.
 

Stijloor

Staff member
Super Moderator
#7
Re: ISO 9001:2000 7.3.5 "Verification" and 7.3.6 "Validation"- Clarification???

I thought this debate was over ....just looked in and found it is still kicking.
Willy,

This is one of of the Cove's hot topics that will always spur debate:argue:, and will never go away, :D no matter what.:yes:

Stijloor.
 

Kevin Mader

One of THE Original Covers!
Staff member
Admin
#8
Re: ISO 9001:2000 7.3.5 "Verification" and 7.3.6 "Validation"- Clarification???

Willy,

Please keep in mind that newcomers often ask repeat questions. This is to be expected, so in essence, the debate is never over.

If the customer requirement is for a car to go 138 mph, then the manufacturer will have to develop a test to validate that its new design meets the need. Validation is done from the customer’s perspective as it’s done to ensure that the product meets user needs and intended uses.

Regards,

Kevin
 

Big Jim

Super Moderator
#9
Re: ISO 9001:2000 7.3.5 "Verification" and 7.3.6 "Validation"- Clarification???

My third and final post of the day stemming from my pre-assessment this week was regarding Design and Development.

The auditor indicated that I had to have proof of verification and validation. The way I explained it to him is:

1. Our verification process is by performing a first article test on prototypes proving that the outputs do meet the inputs of the design.

2. Our validation is doing production functional testing to validate that all deliverables meet customer specifications/ inputs.

He mentioned that I was lacking on the validation part. He said the validation should be how the customer uses the product and that we should gather customer feedback indicating the part conforms to their expectations.

I don't get it? The customer inputs are verified (i.e. customer requirements) which is what the customer wants (by prototype testing). The validation is that the inputs are met by functional test for all deliverable goods (part meets customer required specs).

Why is the feedback needed for validation? I understand that customer satisfaction and customer feedback is a requirement and my company is performing that. How does that fall under Design and Development validation?

Again, I am confused... what am I not understanding?

Thanks again folks!
I don't see enough here to call this a nonconformance. Perhaps there is more to it.

I does sound like the auditor is basing this on what he would like to see or what he usually sees instead of the requirements of the standard.

Lets look at the definitions from ISO 9000:2005. Please note my added emphasis to validation. Also note that NOTE 1 in both do not seem pertinent so I left them out.

verification
conformation, through the provision of objective evidence that specified requirements have been fulfilled.
NOTE 2 Confirmation can comprise activities such as
-- performing alternative calculations,
-- comparing new design specifications with a similar proven design specification,
-- undertaking test and demonstrations, and
-- reviewing documents prior to issue.

validation
confirmation, through the provision of objective evidence, that the requirements for a specific intended use or application have been fulfilled
NOTE 2 The conditions for validation can be real or simulated.

Now lets look at ISO 9001:2000. Please note my emphasis in validation.

7.3.5 Design and development verification

Verification shall be performed in accordance with planned arrangements (see 7.3.1) to ensure that the design and development outputs have met the design and development input requirements. Records of the results of the verification and any necessary actions shall be maintained (see 4.2.4)

7.3.6 Design and development validation

Design and development validation shall be performed in accordance with planned arrangements (see 7.3.1) to ensure that the resulting product is capable of meeting the requirements for the specified application or intended use, where known. Whenever practicable, validation shall be completed prior to the delivery or implementation of the product. Records of the results of validation and any necessary actions shall be maintained (see 4.2.4).

Now lets look at one more from ISO 9001:2000.

4.1c The organization shall determine criteria and methods needed to ensure that both the operation and control of these processes are effective.

Now for my comments.

The main role of validation is to ensure that the resulting product is suitable for the intended use. Have you done what you can to make that determination? Is there any evidence that it is not effective?

Answer those questions for yourself and see where you stand.
 
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